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Multicenter Phase II Study of IMC-A12 in Patients With Thymoma and Thymic Carcinoma Who Have Been Previously Treated With Chemotherapy

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ClinicalTrials.gov Identifier: NCT00965250
Recruitment Status : Completed
First Posted : August 25, 2009
Results First Posted : November 14, 2012
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Arun Rajan, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Thymoma
Thymic Carcinoma
Thymic Carcinoid
Thymic Neuroendocrine Tumors
Intervention Drug: IMC-12
Enrollment 49
Recruitment Details  
Pre-assignment Details The thymic carcinoma cohort was closed after enrolment of 12 participants because of lack of activity.
Arm/Group Title Thymoma Thymic Carcinoma
Hide Arm/Group Description Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas. Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
Period Title: Overall Study
Started 37 12
Completed 37 12
Not Completed 0 0
Arm/Group Title Thymoma Thymic Carcinoma Total
Hide Arm/Group Description Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas. Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas. Total of all reporting groups
Overall Number of Baseline Participants 37 12 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 12 participants 49 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
  75.7%
11
  91.7%
39
  79.6%
>=65 years
9
  24.3%
1
   8.3%
10
  20.4%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 12 participants 49 participants
Female
18
  48.6%
5
  41.7%
23
  46.9%
Male
19
  51.4%
7
  58.3%
26
  53.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 12 participants 49 participants
White, non-Hispanic 25 5 30
White, Hispanic 2 1 3
Black 6 1 7
Asian 4 5 9
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants 12 participants 49 participants
37 12 49
Median age  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 37 participants 12 participants 49 participants
52
(31 to 86)
55
(26 to 71)
52
(26 to 86)
Metastatic Sites   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 12 participants 49 participants
Intrathoracic sites only 18 0 18
Extrathoracic sites(w/without intrathoracic sites 11 12 23
[1]
Measure Description: Data on metastatic sites is provided for 41 patients (29 thymoma, 12 thymic carcinoma) enrolled at the NCI. Eight thymoma patients were enrolled at Memorial Sloan Kettering Cancer Center, New York.
Histological Analysis (WHO classification)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 12 participants 49 participants
AB 2 0 2
B1 4 0 4
B2 15 0 15
B2/B3 3 0 3
B3 9 0 9
C 0 12 12
Not otherwise specified 4 0 4
[1]
Measure Description: WHO (World Health Organization) classification of epithelial thymic malignancies: AB - Mixed, B1 - Predominantly cortical thymoma, B2 - Cortical thymoma, B2/B3 - Cortical thymoma/Well differentiated thymoma, B3 - Well differentiated thymoma, and C - Thymic carcinoma.
Paraneoplastic Syndromes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 12 participants 49 participants
Myastenia gravis 9 0 9
Shulman's syndrome 1 0 1
Pure red-cell aplasia 3 0 3
Crohn's disease 1 0 1
Ulcerative colitis 1 0 1
Mucocutaneous candidiasis 1 0 1
Previous systemic treatment (number of regimens)  
Median (Full Range)
Unit of measure:  Regimens
Number Analyzed 37 participants 12 participants 49 participants
3
(1 to 11)
2
(1 to 11)
2
(1 to 11)
Previous systemic treatment (six or more regimens)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 12 participants 49 participants
10 2 12
Previous chemotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 12 participants 49 participants
One line 12 7 19
Two lines 8 2 10
Three or more lines 17 3 20
Previous platinum treatment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 12 participants 49 participants
37 12 49
Previous anthracycline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 12 participants 49 participants
27 5 32
Investigational drugs   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 12 participants 49 participants
17 4 21
[1]
Measure Description: Counted as previous lines of systemic treatment, but not as previous lines of chemotherapy.
Previous radiotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 12 participants 49 participants
23 4 27
Previous surgery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 12 participants 49 participants
Radical 28 2 30
Debulking 1 1 2
Biopsy 8 9 17
Eastern Cooperative Oncology Group (ECOG) Performance Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 12 participants 49 participants
0 - Normal Activity 3 1 4
1 - Symptoms, but ambulatory 29 8 37
2 - In bed <50% of the time 5 3 8
1.Primary Outcome
Title Objective Response Rate (Partial Response (PR)+Complete Response (CR)) to IMC-A12 Monotherapy in Patients With Advanced or Recurrent Thymoma or Thymic Carcinoma.
Hide Description Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time Frame Patients were assessed for response every 2 cycles (every 6 weeks) while receiving the study drug.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymoma Thymic Carcinoma
Hide Arm/Group Description:
Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
Overall Number of Participants Analyzed 37 12
Measure Type: Number
Unit of Measure: Participants
Complete Response 0 0
Partial Response 5 0
Stable Disease 28 5
Progressive Disease 4 7
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Time Frame 81 months and 17 days
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse events are not separated by group because the adverse events are related to the drug which was the same in both groups.
Arm/Group Title IMC-A12 Monotherapy in Patients
Hide Arm/Group Description:
Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: Participants
49
3.Secondary Outcome
Title Percentage of Participants Who Respond to Treatment
Hide Description Percentage of participants who respond to treatment was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymoma Thymic Carcinoma
Hide Arm/Group Description:
Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
Overall Number of Participants Analyzed 37 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
14
(5 to 29)
0
(0 to 26)
4.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description Disease control rate is defined as objective response plus stable disease.
Time Frame 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymoma Thymic Carcinoma
Hide Arm/Group Description:
Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
Overall Number of Participants Analyzed 37 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
89
(75 to 97)
42
(15 to 72)
5.Secondary Outcome
Title Time to Progression
Hide Description Time between the first day of treatment to the day of disease progression.
Time Frame 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymoma Thymic Carcinoma
Hide Arm/Group Description:
Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
Overall Number of Participants Analyzed 37 12
Median (95% Confidence Interval)
Unit of Measure: Months
9.9
(7.3 to 12.8)
1.7
(0.9 to 2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Thymoma, Thymic Carcinoma
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Kaplan Meier
Comments [Not Specified]
6.Secondary Outcome
Title Overall Survival
Hide Description Time from treatment start date until date of death or date last known alive.
Time Frame 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymoma Thymic Carcinoma
Hide Arm/Group Description:
Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
Overall Number of Participants Analyzed 37 12
Median (95% Confidence Interval)
Unit of Measure: Months
27.5 [1] 
(15.0 to NA)
8.4
(4.7 to 12.8)
[1]
NA represents an undefined upper limit of the confidence interval because there were insufficient events (deaths) for it to be determined.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Thymoma, Thymic Carcinoma
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Kaplan Meier
Comments [Not Specified]
7.Secondary Outcome
Title Median Number of Cycles of Therapy
Hide Description A cycle is defined as 21 days or 6 weeks of therapy.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thymoma Thymic Carcinoma
Hide Arm/Group Description:
Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
Overall Number of Participants Analyzed 37 12
Median (Full Range)
Unit of Measure: Cycles
13
(2 to 46)
2.5
(1 to 8)
8.Secondary Outcome
Title Correlate Response to Therapy With Changes in FDG-PET Imaging
Hide Description Participants with scans that showed neither sufficient shrinkage to qualify as an objective response nor sufficient increase to qualify as disease progression, taking as reference the smallest cumulative longest dimension since start of treatment, to have stable disease.
Time Frame 6 weeks after initiation of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
We did radiological assessment ourselves, and an independent radiological assessment was not undertaken for assessment of response or progression.
Arm/Group Title Thymoma Thymic Carcinoma
Hide Arm/Group Description:
Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events are not separated by group because the adverse events are related to the drug which was the same in both groups.
 
Arm/Group Title IMC-A12 Monotherapy in Patients
Hide Arm/Group Description Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks.
All-Cause Mortality
IMC-A12 Monotherapy in Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IMC-A12 Monotherapy in Patients
Affected / at Risk (%) # Events
Total   29/49 (59.18%)    
Cardiac disorders   
Myocardial infection  1  1/49 (2.04%)  1
Gastrointestinal disorders   
Mucositis Oral  1  1/49 (2.04%)  1
Abdominal pain  1  1/49 (2.04%)  1
Rectal pain  1  1/49 (2.04%)  1
Diarrhea  1  1/49 (2.04%)  1
General disorders   
Death NOS  1  22/49 (44.90%)  22
Chills  1  1/49 (2.04%)  1
Fever  1  1/49 (2.04%)  1
Infections and infestations   
Bronchial infection  1  1/49 (2.04%)  1
Enterocolitis infection  1  1/49 (2.04%)  1
Soft tissue infection  1  1/49 (2.04%)  1
Metabolism and nutrition disorders   
CPK increased  1  1/49 (2.04%)  1
Hyperglycemia  1  1/49 (2.04%)  1
Musculoskeletal and connective tissue disorders   
Bone pain  1  1/49 (2.04%)  1
Generalized muscle weakness  1  1/49 (2.04%)  1
Myositis  1  1/49 (2.04%)  1
Non-cardiac chest pain  1  1/49 (2.04%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, mailgnant and unspecified  1 [1]  2/49 (4.08%)  2
Nervous system disorders   
Seizure  1  1/49 (2.04%)  1
Respiratory, thoracic and mediastinal disorders   
Chest wall pain  1  1/49 (2.04%)  2
Dyspnea  1  3/49 (6.12%)  3
Hypoxia  1  2/49 (4.08%)  2
Lung infection  1  1/49 (2.04%)  1
Respiratory failure  1  2/49 (4.08%)  2
Vascular disorders   
Thromboembolic event  1  1/49 (2.04%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
(not incl cysts and polyps) - Other, specify
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IMC-A12 Monotherapy in Patients
Affected / at Risk (%) # Events
Total   49/49 (100.00%)    
Blood and lymphatic system disorders   
Activated partial thromboplastin time prolonged  1  7/49 (14.29%)  12
Anemia  1  35/49 (71.43%)  105
Edema: limbs  1  1/49 (2.04%)  2
INR increased  1  1/49 (2.04%)  1
Lymphocyte count decreased  1  20/49 (40.82%)  63
lymphocyte count increased  1  8/49 (16.33%)  14
Neutrophil count decreased  1  8/49 (16.33%)  29
Platelet count decreased  1  16/49 (32.65%)  45
White blood cell decreased  1  11/49 (22.45%)  40
Bronchopulmonary hemorrhage  1  3/49 (6.12%)  4
Cardiac disorders   
Acute coronary syndrome  1  2/49 (4.08%)  2
Hypotension  1  2/49 (4.08%)  2
Palpitations  1  1/49 (2.04%)  1
Sinus bradycardia  1  1/49 (2.04%)  1
Ear and labyrinth disorders   
Ear and labyrinth disorders - Other, specify (patient reports of diminished hearing)  1  1/49 (2.04%)  1
Hearing impaired  1  3/49 (6.12%)  4
Tinnitus  1  1/49 (2.04%)  1
Eye disorders   
Dry eye  1  2/49 (4.08%)  2
Eye disorders - Other, specify (Aur; lost vision R eye)  1  2/49 (4.08%)  2
Eye pain  1  1/49 (2.04%)  1
Flashing lights  1  3/49 (6.12%)  3
Floaters  1  4/49 (8.16%)  5
Blurred vision  1  1/49 (2.04%)  1
Conjunctivitis  1  2/49 (4.08%)  2
Gastrointestinal disorders   
Abdominal distention  1  1/49 (2.04%)  1
Abdominal pain  1  3/49 (6.12%)  3
Diarrhea  1  9/49 (18.37%)  22
Dry mouth  1  2/49 (4.08%)  2
Dysgeusia  1  2/49 (4.08%)  2
Gastroesophageal reflux disease  1  2/49 (4.08%)  2
Gastrointestinal disorders - Other, specify  1 [1]  4/49 (8.16%)  5
Hemorroids  1  2/49 (4.08%)  2
Lower gastrointestinal hemorrhage  1  1/49 (2.04%)  3
Mucosal infection  1  2/49 (4.08%)  2
Mucositis oral  1  9/49 (18.37%)  18
Nausea  1  17/49 (34.69%)  27
Oral pain  1  2/49 (4.08%)  3
Rectal pain  1  1/49 (2.04%)  1
Vomiting  1  11/49 (22.45%)  18
Dyspepsia  1  2/49 (4.08%)  2
Constipation  1  7/49 (14.29%)  16
Anorexia  1  20/49 (40.82%)  29
Bloating  1  1/49 (2.04%)  1
General disorders   
Fatigue  1  18/49 (36.73%)  44
Fever  1  3/49 (6.12%)  5
Flu like symptoms  1  1/49 (2.04%)  1
Insomnia  1  2/49 (4.08%)  2
Pain  1  3/49 (6.12%)  6
Tumor pain  1  8/49 (16.33%)  11
Weight loss  1  6/49 (12.24%)  14
Immune system disorders   
Allergic reaction  1  2/49 (4.08%)  2
Allergic rhinitis  1  7/49 (14.29%)  7
Infusion related reaction  1  1/49 (2.04%)  1
Postnasal drip  1  1/49 (2.04%)  1
Infections and infestations   
Infections and infestations - Other, specify (Opportunistic; thrush)  1  2/49 (4.08%)  2
Kidney infection  1  1/49 (2.04%)  1
Tooth infection  1  2/49 (4.08%)  2
Bladder infection  1  3/49 (6.12%)  3
Bronchial infection  1  6/49 (12.24%)  7
Investigations   
Investigations-Other, specify (Bicarbonate, serum-low)  1  1/49 (2.04%)  1
Metabolism and nutrition disorders   
Alanine aminotransferase increased  1  23/49 (46.94%)  60
Alkaline phosphatase increased  1  17/49 (34.69%)  31
Hypercalcemia  1  14/49 (28.57%)  26
Hyperglycemia  1  37/49 (75.51%)  182
Hyperkalemia  1  10/49 (20.41%)  24
Hypermagnesemia  1  9/49 (18.37%)  20
Hypernatremia  1  10/49 (20.41%)  17
Hyperuricemia  1  22/49 (44.90%)  57
Hypoalbuminemia  1  39/49 (79.59%)  110
Hypocalcemia  1  7/49 (14.29%)  20
Hypoglycemia  1  7/49 (14.29%)  10
Hypokalemia  1  6/49 (12.24%)  7
Hypophosphatemia  1  5/49 (10.20%)  11
Hypomagnesemia  1  20/49 (40.82%)  59
Lipase increased  1  6/49 (12.24%)  22
Serum amylase increased  1  8/49 (16.33%)  18
Hyponatremia  1  30/49 (61.22%)  78
Creatinine increased  1  17/49 (34.69%)  68
Aspartate aminotransferase increased  1  23/49 (46.94%)  59
CPK increased  1  9/49 (18.37%)  17
Blood bilirubin increased  1  8/49 (16.33%)  26
Glucose intolerance  1  1/49 (2.04%)  1
Musculoskeletal and connective tissue disorders   
Flank pain  1  2/49 (4.08%)  2
Generalized muscle weakness  1  1/49 (2.04%)  1
Muscle weakness lower limb  1  2/49 (4.08%)  2
Musculoskeletal and connective tissue disorder-Other, specify  1 [2]  13/49 (26.53%)  15
Myalgia  1  5/49 (10.20%)  7
Neck pain  1  1/49 (2.04%)  1
Non-cardiac chest pain  1  3/49 (6.12%)  3
Arthralgia  1  3/49 (6.12%)  3
Back pain  1  2/49 (4.08%)  2
Chest wall pain  1  6/49 (12.24%)  11
Facial muscle weakness  1  1/49 (2.04%)  1
Pain in extremity  1  1/49 (2.04%)  1
Bone pain  1  1/49 (2.04%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, mailgnant and unspecified  1 [3]  1/49 (2.04%)  1
Nervous system disorders   
Dizziness  1  5/49 (10.20%)  8
Headache  1  6/49 (12.24%)  11
Peripheral sensory neuropathy  1  8/49 (16.33%)  12
Presyncope  1  1/49 (2.04%)  1
Tremor  1  2/49 (4.08%)  2
Vertigo  1  5/49 (10.20%)  8
Ataxia  1  1/49 (2.04%)  1
Cognitive disturbance  1  1/49 (2.04%)  1
Confusion  1  1/49 (2.04%)  1
Renal and urinary disorders   
Renal and urinary disorders - Other, specify (urinary hesitancy)  1  1/49 (2.04%)  1
Urinary tract infection  1  4/49 (8.16%)  4
Urinary frequency  1  1/49 (2.04%)  1
Reproductive system and breast disorders   
Erectile dysfunction  1  3/49 (6.12%)  3
Respiratory, thoracic and mediastinal disorders   
Cough  1  16/49 (32.65%)  31
Dyspnea  1  13/49 (26.53%)  20
Epistaxis  1  5/49 (10.20%)  7
Hiccups  1  1/49 (2.04%)  1
Hoarseness  1  4/49 (8.16%)  9
Laryngeal hemorrhage  1  2/49 (4.08%)  2
Sinusitis  1  3/49 (6.12%)  3
Upper respiratory infection  1  8/49 (16.33%)  9
Voice alteration  1  1/49 (2.04%)  1
Nasal congestion  1  1/49 (2.04%)  1
Sore throat  1  1/49 (2.04%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  7/49 (14.29%)  7
Dry skin  1  6/49 (12.24%)  6
Nail discoloration  1  1/49 (2.04%)  2
Nail loss  1  5/49 (10.20%)  5
Rash acneiform  1  1/49 (2.04%)  1
Rash maculo-papular  1  6/49 (12.24%)  8
Skin and subcutaneous tissue disorders - Other, specify  1 [4]  4/49 (8.16%)  4
Skin ulceration  1  1/49 (2.04%)  1
Pruritis  1  1/49 (2.04%)  1
Skin hypopigmentation  1  1/49 (2.04%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
Oral ulcer; oral sensitivity; swallowing
[2]
Cramps; cramps lower extremity; hand cramps; hands cramps; hands, feet; leg cramps
[3]
(incl cysts and polyps)-Other, specify (progression)
[4]
Brittle nails; hives; nail splitting
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Arun Rajan
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-594-5322
EMail: rajana@mail.nih.gov
Layout table for additonal information
Responsible Party: Arun Rajan, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00965250     History of Changes
Other Study ID Numbers: 090212
09-C-0212
First Submitted: August 24, 2009
First Posted: August 25, 2009
Results First Submitted: October 12, 2012
Results First Posted: November 14, 2012
Last Update Posted: December 23, 2016